BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFT, PATIENT, NON-AC-POWERED

    MDR report key: 7017190 · Received November 10, 2017

    Report

    Report Number
    9681684-2017-00089
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Report Date
    November 10, 2017
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON 17TH OCT 2017, ARJOHUNTLEIGH RECEIVED INFORMATION FROM HOSPITAL (B)(6), INDICATING THAT THE NON-ARJOHUNTLEIGH INSTALLATION RAIL SYSTEM (MANUFACTURED BY GULDMANN COMPANY) BECAME UNSTABLE. THE NON-ARJOHUNTLEIGH CEILING RAIL SYSTEM WAS USED WITH ARJOHUNTLEIGH CEILING LIFT: MAXI SKY 600. NO ADVERSE EVENT OCCURRED. IT SHOULD BE EMPHASIZED THAT AFTER THE EVENT, THE CUSTOMER WAS VISITED BY ARJOHUNTLEIGH REPRESENTATIVE TO REMOVE THE ARJOHUNTLEIGH CEILING LIFT FROM THE INSTALLATION. NO MALFUNCTION RELATED TO ARJOHUNTLEIGH CEILING LIFT WAS FOUND. ARJOHUNTLEIGH DEVICE WAS EXCLUDED AS A POTENTIAL CONTRIBUTING CAUSE TO THE REPORTED COMPLAINT. BASED ON THE COLLECTED INFORMATION AND PHOTOGRAPHIC EVIDENCE, ONE OF TWO ANCHOR POINTS (ATTACHING THE RAIL SYSTEM TO THE CEILING) OF THE NON-ARJOHUNTLEIGH RAIL SYSTEM WAS DETACHED. BECAUSE NON-ARJOHUNTLEIGH TRACK WAS USED, WE ARE NOT IN A POSITION TO DETERMINE THE ACTUAL ROOT CAUSE OF THE REPORTED MALFUNCTION. WHILE THE INCIDENT OCCURRED THE ARJOHUNTLEIGH DEVICE WAS NOT BEING USED FOR RESIDENT TRANSFER. MAXI SKY 600 CEILING LIFT WAS PERFORMING ACCORDING TO THE MANUFACTURER'S SPECIFICATION AT TIME INSTABILITY OF THE NON-ARJOHUNTLEIGH INSTALLATION RAIL WAS FOUND. ALTHOUGH NO SERIOUS INJURY TOOK PLACE, WE HAVE REPORTED INVESTIGATED EVENT TO COMPETENT AUTHORITIES, DUE TO THE FACT THAT SUCH CIRCUMSTANCES WITH PATIENT ATTACHED ON THE CEILING INSTALLATION RAIL SYSTEM UPON RECURRENCE MAY POSE A RESIDENT AT RISK.

    Description of Event or Problem · 1

    ON 17TH OCT 2017, ARJOHUNTLEIGH RECEIVED INFORMATION FROM HOSPITAL (B)(6), INDICATING THAT THE NON-ARJOHUNTLEIGH INSTALLATION RAIL SYSTEM (MANUFACTURED BY GULDMANN COMPANY) BECAME UNSTABLE. THE NON-ARJOHUNTLEIGH CEILING RAIL SYSTEM WAS USED WITH ARJOHUNTLEIGH CEILING LIFT: MAXI SKY 600. NO ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801028 LIFT, PATIENT, NON-AC-POWERED MAXI SKY 600 FSA ARJOHUNTLEIGH MAGOG INC. LD05018

    Patients

    Seq Age Sex Outcome Treatment
    1 Other